A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer

The primary objectives of this study are the following: Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC)

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : AMG 102
  • drug : Prednisone
  • drug : Placebo
  • drug : Mitoxantrone

Phase: Phase 1/Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Pathologically confirmed adenocarcinoma of the prostate - Radiographic evidence of metastatic disease - Progressive disease meeting at least one of the following criteria: 1. a sequence of at least 2 rising PSA values measured at a minimum of 1 week apart with a 2 ng/mL minimum starting value, or 2. progression according to RECIST criteria for measurable lesions, or 3. appearance of 2 or more new lesions on bone scan. - History of prior taxane-based chemotherapy for metastatic prostate cancer - For patients without a history of surgical castration, continued GnRH analog administration is required - ECOG Performance status of 0 or 1 - Life expectancy ? 3 months

External Links

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Contact information

Primary Contact:

Denise Haas 6507361252

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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